Abstract

An evidence map is visualized as a starting point for deliberations by trans-disciplinary stakeholders, including microbiologists with interests in the evidence and its influence on health and safety. Available evidence for microbial benefits and risks of the breastmilk ecosystem was structured as an evidence map using established risk analysis methodology. The evidence map based on the published literature and reports included the evidence basis, pro- and contra-arguments with supporting and attenuating evidence, supplemental studies on mechanisms, overall conclusions, and remaining uncertainties. The evidence basis for raw breastmilk included one benefit–risk assessment, systematic review, and systematic review/meta-analysis, and two cohort studies. The evidence basis for benefits was clear, convincing, and conclusive, with supplemental studies on plausible mechanisms attributable to biologically active raw breastmilk. Limited evidence was available to assess microbial risks associated with raw breastmilk and pasteurized donor milk. The evidence map provides transparent communication of the ‘state-of-the-science’ and uncertainties for microbial benefits and risks associated with the breastmilk microbiota to assist in deeper deliberations of the evidence with decision makers and stakeholders. The long-term aims of the evidence map are to foster deliberation, motivate additional research and analysis, and inform future evidence-based policies about pasteurizing donor breastmilk.

Highlights

  • Human experimental evidenceinfants linkingfed infants fed with breastmilk to clinical diseaseoutcomes or health from outcomes from cohort randomized studies, randomized controlled disease or health cohort studies, controlled clinicalclinical trials, and trials, and other observational well as systematic meta-analyses, and other observational studies, asstudies, well asassystematic reviews,reviews, meta-analyses, and quantitaquantitative microbial risk assessments or

  • Cohort studies, or quantitative microbial risk assessments (QMRAs) were identified that estimated the likelihood of infectious diseases transmitted to infants from raw breastmilk

  • Overall biological benefits associated with breastmilk are clear, convincing, and conclusive, with supplemental studies on plausible mechanisms attributed to biologically active raw breastmilk based on the body of evidence summarized

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Summary

Introduction

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Fear and dread of microbes as germs that will kill us may factor strongly into a policy that is becoming more controversial with expanding knowledge of the natural microbiota of milks from -omics studies in this decade: the decision to require pasteurization of breastmilk from donors in most human milk banks around the world [17,18,19,20,21]. Formal methods for benefit–risk assessment [24,25,26] were considered as potential frameworks for future communications with diverse stakeholders about the ‘state of the science’ and uncertainties for evidence of benefits and risks to NICU infants fed raw breastmilk and pasteurized donor milk. Microbiol. 2021, 1, FOR PEER REVIEW exercises of analysis and deliberation planned for this project, rather than as a quantitative analysis of benefits and risks that might be undertaken in the future

Methodologic
Results
Raw Breastmilk Ecosystem
Benefits
Risks: Contra-Argument
Benefit–Risk Conclusions
Remaining Uncertainties
Discussion
Might Scientific Revolutions Be Shifting Our Paradigms?
Updating Preconceived Notions on Breastmilk Ecosystem Structure and Function
Including Benefits of Microbiota-Mediated Colonization Resistance
Updating Earlier Notions from Decision Science
Future Direction

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